Shunji Narumi1, Yoshihiko Watarai2, Norihiko Goto3, Takahisa Hiramitsu2, Makoto Tsujita3, Manabu Okada2, Kenta Futamura3, Toshihide Tomosugi2, Morikuni Nishihira4, Shintarou Sakamoto5, Takaaki Kobayashi6. 1. Transplant Surgery, Kidney Disease Center, Japanese Red Cross Nagoya Daini Hospital, Aichi, Japan. Electronic address: nshunji@nagoya2.jrc.or.jp. 2. Transplant Surgery, Kidney Disease Center, Japanese Red Cross Nagoya Daini Hospital, Aichi, Japan. 3. Transplant Nephrology, Kidney Disease Center, Japanese Red Cross Nagoya Daini Hospital, Aichi, Japan. 4. Division of Kidney Transplant, Masuko Memorial Hospital, Aichi, Japan. 5. Division of Laboratory, Japanese Red Cross Nagoya Daini Hospital, Aichi, Japan. 6. Department of Kidney Transplant, Aichi Medical Hospital, Aichi, Japan.
Abstract
PURPOSE: We evaluated de novo donor-specific antibody (DSA) production of everolimus (EVR)-based immunosuppression for primary kidney transplant recipients involved in the A1202 study at our institute. METHODS:From March 2008 to August 2009, 24 recipients were prospectively randomized into 2 groups. The EVR group received reduced cyclosporin A and EVR. The standard protocol (STD) group received standard cyclosporin A and mycophenolate mofetil. Both groups received basiliximab and steroids. De novo DSA was identified using LABScreen single antigen beads (One Lambda, Canoga Park, Calif., United States). Mean fluorescence intensity (MFI) values > 1000 were considered positive. P < .05 was considered significant. RESULTS:Graft survival was 100% in the EVR group and 90.9% in the STD group. All patients remained on the primary protocol in the EVR group, but 3 patients in the STD group (27.3%) were converted to tacrolimus due to DSA and non-adherence. Estimated glomerular filtration rate was similar in both groups. No EVR group recipients and 9.1% of STD group recipients were treated for T-cell-mediated rejection. No recipients of the EVR group exhibited peritubular capillaritis, while 9.1% in STD group developed chronic active antibody-mediated rejection. LABScreen revealed an accumulative class II DSA production rate of 15.4% in the EVR group and 18.3% in the STD group at 10 years. When the MFI cut-off level was set to 6000, anti-HLA antibody and de novo DSA-free survival was significantly better in the EVR group. CONCLUSIONS: EVR-based immunosuppression provided equivalent or even better clinical outcomes. EVR suppressed de novo DSA production at 10 years follow-up; however, further follow-up is inevitable.
RCT Entities:
PURPOSE: We evaluated de novo donor-specific antibody (DSA) production of everolimus (EVR)-based immunosuppression for primary kidney transplant recipients involved in the A1202 study at our institute. METHODS: From March 2008 to August 2009, 24 recipients were prospectively randomized into 2 groups. The EVR group received reduced cyclosporin A and EVR. The standard protocol (STD) group received standard cyclosporin A and mycophenolate mofetil. Both groups received basiliximab and steroids. De novo DSA was identified using LABScreen single antigen beads (One Lambda, Canoga Park, Calif., United States). Mean fluorescence intensity (MFI) values > 1000 were considered positive. P < .05 was considered significant. RESULTS: Graft survival was 100% in the EVR group and 90.9% in the STD group. All patients remained on the primary protocol in the EVR group, but 3 patients in the STD group (27.3%) were converted to tacrolimus due to DSA and non-adherence. Estimated glomerular filtration rate was similar in both groups. No EVR group recipients and 9.1% of STD group recipients were treated for T-cell-mediated rejection. No recipients of the EVR group exhibited peritubular capillaritis, while 9.1% in STD group developed chronic active antibody-mediated rejection. LABScreen revealed an accumulative class II DSA production rate of 15.4% in the EVR group and 18.3% in the STD group at 10 years. When the MFI cut-off level was set to 6000, anti-HLA antibody and de novo DSA-free survival was significantly better in the EVR group. CONCLUSIONS:EVR-based immunosuppression provided equivalent or even better clinical outcomes. EVR suppressed de novo DSA production at 10 years follow-up; however, further follow-up is inevitable.
Authors: Deirdre Hahn; Elisabeth M Hodson; Lorraine A Hamiwka; Vincent Ws Lee; Jeremy R Chapman; Jonathan C Craig; Angela C Webster Journal: Cochrane Database Syst Rev Date: 2019-12-16
Authors: Safak Gül-Klein; Henriette Hegermann; Robert Röhle; Moritz Schmelzle; Frank Tacke; Wenzel Schöning; Robert Öllinger; Tomasz Dziodzio; Patrick Maier; Julius M Plewe; David Horst; Igor Maximilian Sauer; Johann Pratschke; Nils Lachmann; Dennis Eurich Journal: J Inflamm Res Date: 2021-06-23